Primary Rituximab and Maintenance

This study has been completed.

Sponsor:

Lymphoma Study Association

ClinicalTrials.gov Identifier:

NCT00140582

First Posted: September 1, 2005

Last Update Posted: March 13, 2017

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Primary objective: To evaluate in patients with advanced follicular lymphoma the benefit of maintenance therapy with rituximab after induction of response with chemotherapy plus rituximab in comparison with no maintenance therapy

Secondary objective: To evaluate response rates, event driven survival endpoints (EFS, PFS, OS) and quality of life of four different chemotherapy regimens combined with rituximab, with or without maintenance with rituximab, for first line treatment of advanced stage follicular lymphoma.

Study Design This is an international open-label, multicentre, randomized study with two treatment phases. In the induction phase patients have to respond to 1st line induction treatment in order to be eligible for randomization to the second phase of maintenance treatment or observation. After the maintenance period patients will be included in the follow up phase for 3 years.

Advanced Follicular Lymphoma Evaluating the Benefit of Maintenance Therapy With Rituximab (MabThera®) After Induction of Response With Chemotherapy Plus Rituximab in Comparison With no Maintenance Therapy

rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment

No Intervention: B : no maintenance

No further treatment

Detailed Description:

Study medication

First period: Induction of response with 8 x rituximab combined with 8 cycles of CVP or 6 cycles of CHOP in 21-day cycles or 6 cycles of FCM in 28-day cycles or 6 cycles of MCP in 28-day cycles.

Second period: rituximab 375 mg/m2 every 8 weeks for 24 months (12 injections) or control with no treatment

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Histologically confirmed follicular lymphoma grade 1, 2 or 3a.

Patients previously untreated.

Patients with at least one of the following symptoms requiring initiation of treatment:

Bulky disease at study entry according to the GELF criteria: nodal or extranodal mass > 7cm in its greater diameter

B symptoms

Elevated serum LDH or beta2-microglobulin

involvement of at least 3 nodal sites (each with a diameter greater than 3 cm)

symptomatic splenic enlargement

compressive syndrome

pleural/peritoneal effusion

Age must be > 18 years.

Performance status < 2 on the ECOG scale (see appendix E).

Adequate hematological function within 28 days prior to registration (unless those abnormalities are related to lymphoma extension), this includes:

Hemoglobin ≥ 8.0 g/dl (5.0 mmol/L)

Absolute neutrophil count (ANC) ≥ 1.5 109/L

Platelet count ≥ 100 109/L

Women are not breast feeding, are using effective contraception, are not pregnant and agree not to become pregnant during participation in the trial and during the 12 months thereafter. Men agree not to father a child during participation in the trial and during the 12 months thereafter.

Serious underlying medical conditions, which could impair the ability of the patient to participate in the trial (e.g. ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease). Judgment is up to the investigator.

Life expectancy < 6 months

Known sensitivity or allergy to murine products

Treatment within a clinical trial within 30 days prior to trial entry

Adult patient under tutelage.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140582